Beta-blocker Before Extubation

Not Applicable

Withdrawn

• Conditions: Myocardial Ischemia
• Interventions: Drug: Metoprolol

• Registration Number: NCT00563238
• Lead Sponsor: Gregory A. Schmidt

Brief Summary

Silent myocardial ischemia is known to occur in the general medical intensive care unit population immediately following tracheal extubation. We believe these patients are at risk for primary cardiac events in the 4 hours immediately following extubation. Metoprolol is a selective beta-1 antagonist, with little to no beta-2 activity at low and moderate doses. The cardioprotective effects of beta blockade have been well documented in randomized controlled trials. In patients undergoing extubation, prophylactic use of intravenous metoprolol may reduce post-extubation ischemia events as well as precursors of cardiogenic pulmonary edema (atrial and ventricular wall tension). Our primary hypothesis is that prophylactic metoprolol (titrated to reduce resting heart rate by at least 10%) prior to tracheal extubation will reduce the rate of ischemia as judged by ST segment analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-26
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult medical or cardiac intensive care unit patients on mechanical ventilation who have known coronary artery disease or have at least 2 of the following risk factors for coronary artery disease:

  • Cigarette smoking
  • Hypertension (BP 140/90 or antihypertensive medication)
  • Low HDL-cholesterol (HDL-C) (<40 mg/dL [1.03 mmol/L])
  • Family history of premature CHD (in male first degree relatives <55 years, in female first degree relative <65 years)
  • Age (men 45 years, women 55 years)
  • Diabetes mellitus
  • Symptomatic carotid artery disease
  • Peripheral arterial disease
  • Abdominal aortic aneurysm

Exclusion Criteria

• Arterial hypotension, defined as mean arterial pressure < 60 mmHg or requiring any intravenous vasoactive medication.
• The presence of known reactive airway disease.
• Resting heart rate of <60 in the period prior to tracheal extubation..
• The presence of decompensated congestive heart failure, defined as requiring continuous infusion of an inotropic agent.
• Known hypersensitivity to beta-blockers or any other contraindication to their use.
• Subjects younger than 18 years of age.
• Inability to obtain consent from the subject or the subjects authorized representative.
• Pregnancy
• Digoxin therapy
• Current therapy with a beta-blocker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoprolol	Metoprolol	-

Primary Outcome Measures

Name	Time	Method
The rate of ischemia as judged by ST segment analysis in the 4h following extubation	4 hours

Secondary Outcome Measures

Name	Time	Method
Rate-pressure product following extubation	30min, 2h, 4h
Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation	48h
Pro-BNP levels	30min

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States